- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249975
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm.
At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol.
This study is:
- Prospective
- Multi-center
- Non-randomized
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands
- Academic Medical Center Amsterdam
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Nieuwegein, Netherlands
- St. Antonius Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria Inclusion Criteria
- Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
- Patient is 18 to 80 years of age at the time of consent (inclusive).
- Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
- Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
- Patient is deemed operable per standard institutional criteria.
- BE lesion length <6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
- One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
- BE lesion within the treatment zone should be flat
Exclusion Criteria
- Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
- Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
- Patient refuses or is unable to provide written informed consent.
- Patients that are pregnant.
- Patient with endoscopically active inflammation in the treatment zone.
- Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: C2 CryoBalloon Focal Ablation System
Cryoballoon ablation will be performed on patients with Barrett's Esophagus.
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The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken. Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood. Evaluations include, but are not limited to the following:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of residual Barrett's Esophagus
Time Frame: 12 weeks
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Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of adverse events
Time Frame: 12 weeks
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All adverse events will be reported
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12 weeks
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Patient Pain
Time Frame: post-procedure through 12 week follow-up
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Patient is asked to rate any pain in the treatment area or with swallowing
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post-procedure through 12 week follow-up
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Device Performance
Time Frame: 12 weeks
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All device performance will be reported
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12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacques Bergman, MD, PhD, Academic Medical Centre (Amsterdam)
Publications and helpful links
General Publications
- Friedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30.
- van Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP-0004.A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Barrett's Esophagus
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The Guthrie ClinicActive, not recruiting
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Lucid Diagnostics, Inc.CompletedBarrett Esophagus | Esophageal Adenocarcinoma | Barrett's Esophagus Without Dysplasia | Barretts Esophagus With DysplasiaUnited States, Spain
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Mayo ClinicFred Hutchinson Cancer CenterCompletedBarrett's Esophagus With High Grade Dsyplasia | Early Esophageal CancerUnited States
Clinical Trials on C2 CryoBalloon Focal Ablation System
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Pentax MedicalCompletedEsophageal Squamous Cell DysplasiaChina
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Mayo ClinicPentax MedicalCompleted
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Pentax MedicalEnrolling by invitation
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Pentax MedicalCompletedBarrett EsophagusNetherlands
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University of North Carolina, Chapel HillJohns Hopkins University; PENTAX of America, Inc.RecruitingBarrett Esophagus | Intestinal Metaplasia | Esophageal DysplasiaUnited States
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Pentax MedicalCompletedEsophageal CancerUnited States
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Pentax MedicalCompletedEsophageal CancerNetherlands